SBIR Phase II: Orally-dosed Intestinal Coating for the Treatment of Type 2 Diabetes Inspired from Bariatric Surgery
SBIR II 期:受减肥手术启发,用于治疗 2 型糖尿病的口服肠衣
基本信息
- 批准号:1738372
- 负责人:
- 金额:$ 50万
- 依托单位:
- 依托单位国家:美国
- 项目类别:Standard Grant
- 财政年份:2017
- 资助国家:美国
- 起止时间:2017-09-15 至 2021-06-30
- 项目状态:已结题
- 来源:
- 关键词:
项目摘要
The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project addresses the healthcare needs of the 27 million Americans and 300 million patients globally suffering with type 2 diabetes (T2D). These patients are desperate for a safe treatment that reestablishes glycemic control to augment or replace current management strategies such as metformin and insulin, which only slow the progression of the disease. This proposal provides a unique approach to T2D based on an orally delivered intestinal coating that mimics the beneficial metabolic effects of bariatric surgery. The potential commercial impact of this novel treatment is highly significant as the total estimated cost of diabetes management in the US is upwards of $245 billion, and rising. Overall, an astounding 1 in 5 US health care dollars is used for the care of people with diabetes. Therefore, major insurers are very interested in the reimbursement of alternative approaches for treating T2D, thereby lessening the national cost burden.The proposed project supports the further development of an entirely novel treatment for T2D based on new insights from bariatric surgery. The medical community has recently recognized that certain bariatric procedures involving duodenal exclusion confer profound and immediate benefits in glucose tolerance. Sleeve-type medical devices have provided clinical validation for this approach, but such devices are invasive and not currently approved due to safety issues. The investigators propose a non-invasive and safe orally-delivered intestinal coating which is expected to provide the same effect as surgery and implanted sleeves, but requires neither a specialist nor sedation. This proposal describes in-vitro and in-vivo experiments that build on positive results of the Phase I project, and drive the company towards human clinical trials. Specific Aim-1 is to optimize the active lead compound through evaluation of a limited number of rational structural variations. Specific Aim 2 is to demonstrate the dose-dependent efficacy and safety of lead formulations in a chronic diabetic animal model. Consultation with leading endocrinologists, gastroenterologists, and material scientists has guided the selection of the materials and methods of this proposal. Completion of the studies outlined in the NSF SBIR Phase II proposal will accelerate clinical translation, bringing this novel treatment closer to patients in need.
这项小型企业创新研究(SBIR)第二阶段项目的更广泛影响/商业潜力解决了2700万美国人和全球3亿2型糖尿病(T2 D)患者的医疗保健需求。这些患者迫切需要一种安全的治疗方法来重建血糖控制,以加强或取代目前的管理策略,如二甲双胍和胰岛素,这些策略只能减缓疾病的进展。该提案提供了一种独特的T2 D治疗方法,该方法基于经口递送的肠包衣,其模拟减肥手术的有益代谢作用。这种新型治疗方法的潜在商业影响非常显著,因为美国糖尿病管理的总估计成本超过2450亿美元,并且还在上升。总体而言,令人震惊的是,每5美元中就有1美元用于糖尿病患者的护理。因此,主要保险公司对T2 D治疗的替代方法的报销非常感兴趣,从而减轻国家的成本负担。拟议的项目支持基于减肥手术的新见解进一步开发T2 D的全新治疗方法。医学界最近认识到,某些涉及十二指肠切除术的减肥手术对糖耐量具有深远而直接的益处。套筒型医疗器械已经为这种方法提供了临床验证,但这种器械是侵入性的,目前由于安全问题尚未获得批准。研究人员提出了一种非侵入性和安全的口服肠道涂层,预计将提供与手术和植入套管相同的效果,但既不需要专家也不需要镇静。该提案描述了建立在I期项目积极结果基础上的体外和体内实验,并推动公司进行人体临床试验。具体目标-1是通过评价有限数量的合理结构变化来优化活性先导化合物。具体目标2是证明铅制剂在慢性糖尿病动物模型中的剂量依赖性疗效和安全性。与领先的内分泌学家、胃肠病学家和材料科学家的磋商指导了本提案的材料和方法的选择。NSF SBIR II期提案中概述的研究的完成将加速临床转化,使这种新型治疗更接近有需要的患者。
项目成果
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Thomas Jozefiak其他文献
Quality of life in children with OCD before and after treatment
强迫症儿童治疗前后的生活质量
- DOI:
10.1007/s00787-014-0659-z - 发表时间:
2015 - 期刊:
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Consumer satisfaction with the Child and Adolescent Mental Health Service and its association with treatment outcome: A 3–4-year follow-up study
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- DOI:
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2015 - 期刊:
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Adversarial Growth in Olympic Swimmers: Constructive Reality or Illusory Self-Deception?
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- DOI:
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2023 - 期刊:
- 影响因子:0
- 作者:
A. Holte;M. Barry;Mona Bekkhus;Anne Inger Helmen;Borge;L. Bowes;F. Casas;O. Friborg;B. Grinde;B. Headey;Thomas Jozefiak;R. Lekhal;N. Marks;Ruud;Muffels;R. B. Nes;E. Røysamb;J. Thimm;Svenn;Torgersen;G. Trommsdorff;R. Veenhoven;Joar Vittersø;T. Waaktaar;G. Wagner;C. Arfwedson;Wang;B. Wold;H. Zachrisson - 通讯作者:
H. Zachrisson
What Predicts a Good Adolescent to Adult Transition in ADHD? The Role of Self-Reported Resilience
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- DOI:
10.1177/1087054715604362 - 发表时间:
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Måleegenskaper ved den norske versjonen av Social Communication Questionnaire (SCQ)
社交沟通问卷(SCQ)
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Thomas Jozefiak的其他文献
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